Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single B… (NCT04941729) | Clinical Trial Compass
TerminatedNot Applicable
Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System
Stopped: Change on clinical and marketing strategy for the devices
China24 participantsStarted 2022-06-24
Plain-language summary
The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Data collected in this study will be used to support National Medical Products Administration (NMPA) regulatory approval of OR3O™ Dual Mobility System in China as well as to support and maintain product registration in global markets.
Primary Objective: Assess safety and efficacy of the OR3O™ Dual Mobility System in Primary THA at 1 year postoperative.
Secondary Objective(s): Assess safety and efficacy of the OR3O™ Dual Mobility System and compatible components in Primary THA up to 2 years after surgery.
Other Objective(s): Assess the hip dislocation and hospital readmission up to 2 years after device implantation.
4 study sites in China.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System or single-bearing design Total Hip System in primary total hip replacement in the Investigator's judgement.
* Subject is skeletally mature in the Investigator's judgement.
* Subject is 18 - 80 years old (inclusive).
* Subject is receiving total hip replacement for the first time on the affected hip.
* Subject has any of the following conditions:
* Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis(RA);
* Fracture or avascular necrosis of the femoral head;
* All forms of osteoarthritis(OA);
* Patients with hips at risk of dislocation;
* Femoral neck fracture or proximal hip joint fracture.
* Subject provides written informed consent for study participation using an Ethical Committee (EC) approved consent form before any study procedures are performed, including pre-operative data review and/or collection of data on electronic Case Report Forms (eCRFs).
* Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
* Subjects with preoperative HHS ≤ 79 (fair or worse category).
Exclusion Criteria:
* Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:
* blood supply limitations;
* insufficient quantity or quality of bone support, e.g., osteoporosis, metaboli…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months